The purpose of this study is to see what effect an investigational drug (BMS-354825) has on subjects who are currently in the myeloid blast phase of chronic myeloid leukemia (CML) and who are either resistant to or intolerant of imatinib mesylate. Another purpose of the study is to see what side effects this drug may have on subjects.

Condition	Treatment or Intervention	Phase
Chronic Myeloid Leukemia Blast Crisis	Drug: BMS-354825	Phase II

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Subjects with myeloid blast phase chronic myeloid leukemia
• Subjects who are either resistant or intolerant of imatinib mesylate

Exclusion Criteria:

• Subjects who are eligible and willing to undergo transplantation
• Serious uncontrolled medical disorder or active infection
• Uncontrolled or significant heart problems, such as congestive heart failure, recent heart attack, etc.
• Subjects receiving medications that may affect heart rhythm
• Other malignancy/cancer other than CML
• History of significant bleeding disorder unrelated to CML
• Pregnant or breastfeeding women (subjects must avoid becoming pregnant)
• Subjects received imatinib within 7 days, interferon or cytarabine within 14 days, a targeted anticancer medication within 14 days, an antineoplastic agent (other than hydroxyurea or anagrelide) within 28 days, or any other investigation medication in 28 days
• Subject is receiving medications that affect platelet function or an anticoagulant

BMS Call Center 1-877-526-7327      1-866-892-1BMS  Ext. 153 
BMS Call Center Outside the US and Canada      1-215-347-4079 

Alabama
      Local Institution, Birmingham,  Alabama,  United States; Recruiting
Arizona
      Local Institution, Phoenix,  Arizona,  United States; Not yet recruiting
California
      Local Institution, Los Angeles,  California,  United States; Recruiting
      Local Institution, Stanford,  California,  United States; Recruiting
      Local Institution, La Jolla,  California,  United States; Not yet recruiting
      Local Institution, Vallejo,  California,  United States; Not yet recruiting
      Local Institution, Anaheim,  California,  United States; Not yet recruiting
Colorado
      Local Institution, Denver,  Colorado,  United States; Recruiting
      Local Institution, Colorado Springs,  Colorado,  United States; Not yet recruiting
Connecticut
      Local Institution, Hartford,  Connecticut,  United States; Not yet recruiting
      Local Institution, West Haven,  Connecticut,  United States; Not yet recruiting
District of Columbia
      Local Institution, Washington,  District of Columbia,  United States; Not yet recruiting
Florida
      Local Institution, Tampa,  Florida,  United States; Not yet recruiting
      Local Institution, Jacksonville,  Florida,  United States; Not yet recruiting
Georgia
      Local Institution, Atlanta,  Georgia,  United States; Recruiting
      Local Institution, Tucker,  Georgia,  United States; Not yet recruiting
Illinois
      Local Institution, Chicago,  Illinois,  United States; Recruiting
      Local Institution, Chicago,  Illinois,  United States; Not yet recruiting
Indiana
      Local Institution, Indianapolis,  Indiana,  United States; Not yet recruiting
Iowa
      Local Institution, Iowa City,  Iowa,  United States; Not yet recruiting
Kansas
      Local Institution, Kansas City,  Kansas,  United States; Not yet recruiting
Kentucky
      Local Institution, Louisville,  Kentucky,  United States; Recruiting
      Local Institution, Lexington,  Kentucky,  United States; Not yet recruiting
Louisiana
      Local Institution, Shreveport,  Louisiana,  United States; Not yet recruiting
Maryland
      Local Institution, Baltimore,  Maryland,  United States; Not yet recruiting
Massachusetts
      Local Institution, Boston,  Massachusetts,  United States; Not yet recruiting
Michigan
      Local Institution, Detroit,  Michigan,  United States; Recruiting
Minnesota
      Local Institution, Rochester,  Minnesota,  United States; Not yet recruiting
Missouri
      Local Institution, St. Louis,  Missouri,  United States; Not yet recruiting
Nebraska
      Local Institution, Omaha,  Nebraska,  United States; Not yet recruiting
      Local Institution, Omaha,  Nebraska,  United States; Not yet recruiting
New Jersey
      Local Institution, Hackensack,  New Jersey,  United States; Recruiting
      Local Institution, New Brunswick,  New Jersey,  United States; Not yet recruiting
New Mexico
      Local Institution, Albuquerque,  New Mexico,  United States; Not yet recruiting
New York
      Local Institution, New York,  New York,  United States; Not yet recruiting
      Local Institution, Buffalo,  New York,  United States; Not yet recruiting
North Carolina
      Local Institution, Chapel Hill,  North Carolina,  United States; Not yet recruiting
      Local Institution, Durham,  North Carolina,  United States; Not yet recruiting
Ohio
      Local Institution, Columbus,  Ohio,  United States; Not yet recruiting
Oregon
      Local Institution, Portland,  Oregon,  United States; Not yet recruiting
Pennsylvania
      Local Institution, Pittsburgh,  Pennsylvania,  United States; Recruiting
Tennessee
      Local Institution, Nashville,  Tennessee,  United States; Not yet recruiting
Texas
      Local Institution, Houston,  Texas,  United States; Recruiting
      Local Institution, Dallas,  Texas,  United States; Not yet recruiting
Washington
      Local Institution, Seattle,  Washington,  United States; Not yet recruiting
Australia, New South Wales
      Local Institution, Sydney,  New South Wales,  Australia; Recruiting
Australia, Queensland
      Local Institution, South Brisbane,  Queensland,  Australia; Recruiting
Australia, South Australia
      Local Institution, Adelaide,  South Australia,  Australia; Recruiting
Australia, Victoria
      Local Institution, East Melbourne,  Victoria,  Australia; Recruiting
Australia, Western Australia
      Local Institution, Perth,  Western Australia,  Australia; Not yet recruiting
Austria
      Local Institution, Wien,  Austria; Recruiting
Belgium
      Local Institution, B-Leuven,  Belgium; Not yet recruiting
      Local Institution, Edegem,  Belgium; Not yet recruiting
      Local Institution, Yvoir,  Belgium; Not yet recruiting
      Local Institution, BRUXELLES,  Belgium; Not yet recruiting
Canada, Alberta
      Local Institution, Edmonton,  Alberta,  Canada; Not yet recruiting
Canada, British Columbia
      Local Institution, Vancouver,  British Columbia,  Canada; Not yet recruiting
Canada, Ontario
      Local Institution, Toronto,  Ontario,  Canada; Not yet recruiting
Canada, Quebec
      Local Institution, Montreal,  Quebec,  Canada; Recruiting
China
      Local Institution, Beijing,  China; Not yet recruiting
      Local Institution, Beijing,  China; Not yet recruiting
      Local Institution, Shanghai,  China; Not yet recruiting
Denmark
      Local Institution, Aarhus,  Denmark; Not yet recruiting
Finland
      Local Institution, Helsinki,  Finland; Not yet recruiting
France
      Local Institution, Poitiers cedex,  France; Recruiting
      Local Institution, Pessac,  France; Recruiting
      Local Institution, Paris Cedex 10,  France; Recruiting
      Local Institution, Lyon Cedex 03,  France; Recruiting
      Local Institution, Lille,  France; Recruiting
      Local Institution, Strasbourg Cedex,  France; Recruiting
      Local Institution, Nantes,  France; Recruiting
Germany
      Local Institution, Hamburg,  Germany; Recruiting
      Local Institution, Mainz,  Germany; Recruiting
      Local Institution, Mannheim,  Germany; Recruiting
      Local Institution, Dresden,  Germany; Not yet recruiting
      Local Institution, Leipzig,  Germany; Not yet recruiting
Hungary
      Local Institution, Budapest,  Hungary; Not yet recruiting
Ireland
      Local Institution, Dublin,  Ireland; Not yet recruiting
Ireland, Galway
      Local Institution, Co Galway,  Galway,  Ireland; Not yet recruiting
Israel
      Local Institution, RAMAT-GAN,  Israel; Recruiting
Italy
      Local Institution, Bologna,  Italy; Recruiting
      Local Institution, Roma,  Italy; Recruiting
      Local Institution, Orbassano,  Italy; Not yet recruiting
      Local Institution, Milano,  Italy; Not yet recruiting
      Local Institution, Bari,  Italy; Not yet recruiting
      Local Institution, Napoli,  Italy; Not yet recruiting
      Local Institution, Napoli,  Italy; Not yet recruiting
Korea, Republic of
      Local Institution, Seoul 150-173,  Korea, Republic of; Recruiting
      Local Institution, Seoul,  Korea, Republic of; Not yet recruiting
      Local Institution, Seoul,  Korea, Republic of; Not yet recruiting
      Local Institution, Gwangju,  Korea, Republic of; Not yet recruiting
Netherlands
      Local Institution, Rotterdam,  Netherlands; Not yet recruiting
      Local Institution, Nijmegen,  Netherlands; Not yet recruiting
Norway
      Local Institution, Trondheim,  Norway; Not yet recruiting
Philippines
      Local Institution, Quezon City,  Philippines; Not yet recruiting
Poland
      Local Institution, Warsaw,  Poland; Not yet recruiting
      Local Institution, Lodz,  Poland; Not yet recruiting
      Local Institution, Szczecin,  Poland; Not yet recruiting
      Local Institution, Wroclaw,  Poland; Not yet recruiting
      Local Institution, Lublin,  Poland; Not yet recruiting
      Local Institution, Gdansk,  Poland; Not yet recruiting
      Local Institution, Krakow,  Poland; Not yet recruiting
      Local Institution, Poznan,  Poland; Not yet recruiting
Russian Federation
      Local Institution, Moscow,  Russian Federation; Not yet recruiting
      Local Institution, St Petersburg,  Russian Federation; Not yet recruiting
      Local Institution, Moscow,  Russian Federation; Not yet recruiting
Singapore
      Local Institution, Singapore,  Singapore; Recruiting
South Africa, Free State
      Local Institution, Bloemfontein,  Free State,  South Africa; Not yet recruiting
South Africa, Gauteng
      Local Institution, Groenkloof,  Gauteng,  South Africa; Not yet recruiting
      Local Institution, PARKTOWN,  Gauteng,  South Africa; Not yet recruiting
      Local Institution, Johannesburg,  Gauteng,  South Africa; Not yet recruiting
South Africa, Western Cape
      Local Institution, Plumstead,  Western Cape,  South Africa; Not yet recruiting
Spain
      Local Institution, Barcelona,  Spain; Not yet recruiting
      Local Institution, Madrid,  Spain; Not yet recruiting
      Local Institution, Madrid,  Spain; Not yet recruiting
Sweden
      Local Institution, Uppsala,  Sweden; Recruiting
      Local Institution, Stockholm,  Sweden; Not yet recruiting
      Local Institution, GOTHENBURG,  Sweden; Not yet recruiting
      Local Institution, Lund,  Sweden; Recruiting
      Local Institution, Umea,  Sweden; Not yet recruiting
Switzerland
      Local Institution, Basel,  Switzerland; Recruiting
Taiwan, Province of China
      Local Institution, Taipei,  Taiwan, Province of China; Recruiting
      Local Institution, Taipei,  Taiwan, Province of China; Recruiting
      Local Institution, Taoyuan,  Taiwan, Province of China; Not yet recruiting
United Kingdom, Central
      Local Institution, Glasgow,  Central,  United Kingdom; Recruiting
United Kingdom, Greater London
      Local Institution, London,  Greater London,  United Kingdom; Recruiting
United Kingdom, Tyne and Wear
      Local Institution, Newcastle upon Tyne,  Tyne and Wear,  United Kingdom; Not yet recruiting

Study ID Numbers:  CA180-006
Record last reviewed:  March 2005
Last Updated:  March 31, 2005
Record first received:  January 13, 2005
ClinicalTrials.gov Identifier:  NCT00101816
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08